The present invention relates to closure devices, and more particularly to artificial sphincters.
A large number of temporary and permanent ostomy procedures are undertaken by surgeons each year to correct some difficulty in the intestinal tract, such as an obstruction or cancer in the tract. Most commonly, during the procedure the intestine is severed and an end of the intestine is brought through an incision in the abdominal wall. The surgeon then secures the intestine end adjacent the patient's skin, and forms an opening, termed a "stoma", at the juncture of the intestine and skin to permit passage of faecal matter outside the patient's body. In the case of a colostomy procedure, an end of the colon is joined to the skin to form the stoma. In the case of an ileostomy procedure, an end of the ileum is used to form the stoma, resulting in passage of corrosive fluids containing digestive enzymes and acids outside the patient's body.
The ostomy procedure results in loss of faecal continence for the patient, and typically the patient has been required to wear a pouch on the outside of the body in order to collect the faecal matter passing through the stoma. In an attempt to overcome incontinence, many physicians have advised daily irrigation of the intestine by the patient through the stoma. However, the irrigation procedure is very time consuming and inconvenient, and has not alleviated the need for use of stoma bags in many patients, particularly on social occasions. Further, the irrigation procedure may result in ulceration or inadvertent perforation of the intestine. Surgical attempts have also been made to secure continence, such as by formation of a so-called "Kock Pouch", but the procedures have been accompanied by complications.
It has also been proposed to achieve continence with various types of closure devices for the stoma. Such a device should assure adequate closure of the intestine in order to prevent loss of confidence by the patient, particularly in social surroundings, else the patient is required to use a stoma bag which defeats the purpose of the closure device. On the other hand, an adequate seal must be obtained while applying minimal forces against the intestine in order to prevent necrosis. Further, the device should permit simplified placement for patient convenience, and should be light in weight to minimize the possibility of complications resulting from gravitational forces in the region of the stoma and to assure patient comfort.